| CTRI Number |
CTRI/2021/01/030580 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
12/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of polyherbal oil nasal instillation in childhood Asthma. |
|
Scientific Title of Study
|
‘A comparative study on the efficacy of Palandu Taila and Anu Taila Pratimarsha Nasya in children with Tamaka Shwasa’
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhiraj Khobragade |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 26 Mahatma Gandhi Ayurved College Hospital and Research Centre
Wardha Maharastra
Wardha
MAHARASHTRA
442001
India |
| Phone |
7709593585 |
| Fax |
|
| Email |
drdhirajkhobragade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothy K B |
| Designation |
HOD & Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 26 Mahatma Gandhi Ayurved College Hospital and Research Centre
Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8999314535 |
| Fax |
|
| Email |
jyothybmenon@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyothy K B |
| Designation |
HOD & Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 26 Mahatma Gandhi Ayurved College Hospital and Research Centre
Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8999314535 |
| Fax |
|
| Email |
jyothybmenon@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod wardha Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Datta meghe Institute of Medical Sciences |
| Address |
sawangi wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dhiraj Khobragade |
Mahatma Gandhi Ayurved College and Hospital |
Room no 26. Department of Balrog.
Wardha
MAHARASHTRA |
7709593585
drdhirajkhobragade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J709||Respiratory conditions due to unspecified external agent, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Palandu Taila and Anu Taila |
1 drop in each Nostril in Morning for 14 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants above 5 year of age to 12 year will be selected irrespective of gender, caste & socioeconomic status and religion.
Children suffering from Tamaka Shwasa in Avegavastha.
Children willing to participate in the study and whose parents give consent.
|
|
| ExclusionCriteria |
| Details |
Severe cases of Asthma with complications like suspected infection, large airway lesions, heart disease, other pulmonary diseases etc.
Other systemic, endocrine, chronic, debilitating disorder associated with any degree of
Asthma.
Patient with acute or severe exacerbation and Status Asthmaticus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Palandu Taila and Anu Taila Pratimarsha Nasya are effective in the management of Tamaka shwasa in children. |
14 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study Palandu Taila Pratimarsha Nasya and Anu Taila Pratimarsha Nasya will be given 1 drop in each Nostril in Morning for 7 days followed by follow up on 14 days in the Management of Tamaka Shwasa in children and Assesement will be done on the basis of Subjective and Objective Criteria which Taila is more effective in the treatment of Tamaka Shwasa in Children
|